UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011329 |
|---|---|
| Receipt number | R000013268 |
| Scientific Title | Outcomes and risk stratification after endovascular therapy for patients with PAD |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2013/09/04 19:13:36 |
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Basic information
Public title
Outcomes and risk stratification after endovascular therapy for patients with PAD
Acronym
OPEN-PAD trial
Scientific Title
Outcomes and risk stratification after endovascular therapy for patients with PAD
Scientific Title:Acronym
OPEN-PAD trial
Region
| Japan |
Condition
Condition
PAD
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical outcome and risk factor of PAD patient with EVT.
Basic objectives2
Others
Basic objectives -Others
To evaluate changing of QOL in PAD patient with EVT.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all cause death
non fatal myocardiac infarction
stroke
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PAD patient recommended endo vascular therapy.
over 20 years old.
not exclusion criteria patient.
patient with consent of EVT.
Key exclusion criteria
patient unavailable of anti platelet agents and anticoagulant.
Allergy of contrast agents.
Life expectancy 12 months.
During pregnancy and suckling.
inappropriate patient determined from study director.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's medical university
Division name
cardiology
Zip code
Address
8-1, kawada-cho, shinjuku-ku, tokyo
TEL
03-3353-8111
nakaomasashi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Nakao |
Organization
Tokyo Women's medical university
Division name
cardiology
Zip code
Address
8-1, kawada-cho, shinjuku-ku, tokyo
TEL
03-3353-8111
Homepage URL
nakaomasashi@gmail.com
Sponsor or person
Institute
Tokyo Women's medical university
department of cardiology
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
MACE, MACLE, cause of death, major or minor amputation, QOL score etc
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013268
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
